Patients with adolescent idiopathic scoliosis perceive positive improvements regardless of change in the Cobb angle - Results from a randomized controlled trial comparing a 6-month Schroth intervention added to standard care and standard care alone. SOSORT 2018 Award winner.

BACKGROUND: The Cobb angle is proposed as the "disease process" outcome for scoliosis research because therapies aim to correct or stop curve progression. While the Scoliosis Research Society recommends the Cobb angle as the primary outcome, the Society on Scoliosis Orthopaedic and Rehabilitation Treatment prioritises, as a general goal, patient related outcomes over Cobb angle progression. OBJECTIVE: To determine the threshold of change in the Cobb angle in adolescents with idiopathic scoliosis (AIS) who perceive improvement in a 6-months randomized controlled trial comparing a Schroth exercise intervention added to the standard of care to the standard of care alone. METHODS: This is a secondary analysis of data from a randomized controlled trial of 50 patients with AIS, with curves ranging from 10° to 45°, with or without a brace. Participants with diagnoses other than AIS, surgical candidates or patients who had scoliosis surgery were excluded. The 6-month interventions consisted of Schroth exercises added to standard-of-care (observation or bracing) with daily home exercises and weekly therapy sessions (Schroth) or standard-of-care alone (Control). The anchor method for estimating the minimal important difference (MID) in the largest Cobb angles (LC) was used. Patient-reported change in back status over the 6-month treatment period was measured using the Global Rating of Change (GRC) scale as anchor varying from - 7 ("great deal worse") to + 7 ("great deal better"). Participants were divided into two groups based on GRC scores: Improved (GRC ≥2) or Stable/Not Improved (GRC ≤1). MID was defined as the change in the LC that most accurately predicted the GRC classification as per the receiver operating characteristic curve (ROC). RESULTS: The average age was 13.4 ± 1.6 years and the average LC was 28.5 ± 8.8 °s. The average GRC in the control group was - 0.1 ± 1.6, compared to + 4.4 ± 2.2 in the Schroth group. The correlation between LC and GRC was adequate (r = - 0.34, p < 0.05). The MID for the LC was 1.0 °. The area under the ROC was 0.69 (0.52-0.86), suggesting a 70% chance to properly classify a patient as perceiving No Improvement/Stable or Improvement based on the change in the LC. CONCLUSION: Patients undergoing Schroth treatment perceived improved status of their backs even if the Cobb angle did not improve beyond the conventionally accepted threshold of 5°. Standard of care aims to slow/stop progression while Schroth exercises aim to improve postural balance, signs and symptoms of scoliosis. Given the very small MID, perceived improvement in back status is likely due to something other than the Cobb angle. This study warrants investigating alternatives to the Cobb angle that might be more relevant to patients. TRIAL REGISTRATION: ClinicalTrials.gov , NCT01610908 . Retrospectively registered on April 2, 2012 (first posted on June 4, 2012 - https://clinicaltrials.gov/ct2/keydates/NCT01610908 ).

Schroth physiotherapeutic scoliosis-specific exercises for adolescent idiopathic scoliosis: how many patients require treatment to prevent one deterioration? - results from a randomized controlled trial - "SOSORT 2017 Award Winner".

BACKGROUND: Recent randomized controlled trials (RCTs) support using physiotherapeutic scoliosis-specific exercises (PSSE) for adolescents with idiopathic scoliosis (AIS). All RCTs reported statistically significant results favouring PSSE but none reported on clinical significance. The number needed to treat (NNT) helps determine if RCT results are clinically meaningful. The NNT is the number of patients that need to be treated to prevent one bad outcome in a given period. A low NNT suggests that a therapy has positive outcomes in most patients offered the therapy. The objective was to determine how many patients require Schroth PSSE added to standard care (observation or brace treatment) to prevent one progression (NNT) of the Largest Curve (LC) or Sum of Curves (SOC) beyond 5° and 10°, respectively over a 6-month interval. METHODS: This was a secondary analysis of a RCT. Fifty consecutive participants from a scoliosis clinic were randomized to the Schroth PSSE + standard of care group (n = 25) or the standard of care group (n = 25).We included males and females with AIS, age 10-18 years, all curve types, with curves 10°- 45°, with or without brace, and all maturity levels. We excluded patients awaiting surgery, having had surgery, having completed brace treatment and with other scoliosis diagnoses. The local ethics review board approved the study (Pro00011552).The Schroth intervention consisted of weekly 1-h supervised Schroth PSSE sessions and a daily home program delivered over six months in addition to the standard of care. A prescription algorithm was used to determine which exercises patients were to perform. Controls received only standard of care.Cobb angles were measured using a semi-automatic system from posterior-anterior standing radiographs at baseline and 6 months.We calculated absolute risk reduction (ARR) and relative risk reduction (RRR). The NTT was calculated as: NNT = 1/ARR. Patients with missing values (PSSE group; n = 2 and controls; n = 4) were assumed to have had curve progression (worst case scenario). The RRR is calculated as RRR = ARR/CER. RESULTS: For LC, NNT = 3.6 (95% CI 2.0-28.2), and for SOC, NNT = 3.1 (95% CI 1.9-14.2). The corresponding ARR was 28% for LC and 32% for the SOC. The RRR was 70% for LC and 73% for the SOC. Patients with complete follow-up attended 85% of prescribed visits and completed 82.5% of the home program. Assuming zero compliance after dropout, 76% of visits were attended and 73% of the prescribed home exercises were completed. CONCLUSIONS: The short term of Schroth PSSE intervention added to standard care provided a large benefit as compared to standard care alone. Four (LC and SOC) patients require treatment for the additional benefit of a 6-month long Schroth intervention to be observed beyond the standard of care in at least one patient. TRIAL REGISTRATION: NCT01610908 April 2, 2012.

Schroth Physiotherapeutic Scoliosis-Specific Exercises Added to the Standard of Care Lead to Better Cobb Angle Outcomes in Adolescents with Idiopathic Scoliosis - an Assessor and Statistician Blinded Randomized Controlled Trial.

BACKGROUND: The North American non-surgical standard of care for adolescent idiopathic scoliosis (AIS) includes observation and bracing, but not exercises. Schroth physiotherapeutic scoliosis-specific exercises (PSSE) showed promise in several studies of suboptimal methodology. The Scoliosis Research Society calls for rigorous studies supporting the role of exercises before including it as a treatment recommendation for scoliosis. OBJECTIVES: To determine the effect of a six-month Schroth PSSE intervention added to standard of care (Experimental group) on the Cobb angle compared to standard of care alone (Control group) in patients with AIS. METHODS: Fifty patients with AIS aged 10-18 years, with curves of 10°-45° and Risser grade 0-5 were recruited from a single pediatric scoliosis clinic and randomized to the Experimental or Control group. Outcomes included the change in the Cobb angles of the Largest Curve and Sum of Curves from baseline to six months. The intervention consisted of a 30-45 minute daily home program and weekly supervised sessions. Intention-to-treat and per protocol linear mixed effects model analyses are reported. RESULTS: In the intention-to-treat analysis, after six months, the Schroth group had significantly smaller Largest Curve than controls (-3.5°, 95% CI -1.1° to -5.9°, p = 0.006). Likewise, the between-group difference in the square root of the Sum of Curves was -0.40°, (95% CI -0.03° to -0.8°, p = 0.046), suggesting that an average patient with 51.2° at baseline, will have a 49.3° Sum of Curves at six months in the Schroth group, and 55.1° in the control group with the difference between groups increasing with severity. Per protocol analyses produced similar, but larger differences: Largest Curve = -4.1° (95% CI -1.7° to -6.5°, p = 0.002) and [Formula: see text] (95% CI -0.8 to 0.2, p = 0.006). CONCLUSION: Schroth PSSE added to the standard of care were superior compared to standard of care alone for reducing the curve severity in patients with AIS. TRIAL REGISTRATION: NCT01610908.

The effect of Schroth exercises added to the standard of care on the quality of life and muscle endurance in adolescents with idiopathic scoliosis-an assessor and statistician blinded randomized controlled trial: "SOSORT 2015 Award Winner".

BACKGROUND: In North America, care recommendations for adolescents with small idiopathic scoliosis (AIS) curves include observation or bracing. Schroth scoliosis-specific exercises have demonstrated promising results on various outcomes in uncontrolled studies. This randomized controlled trial (RCT) aimed to determine the effect of Schroth exercises combined with the standard of care on quality-of-life (QOL) outcomes and back muscle endurance (BME) compared to standard of care alone in patients with AIS. MATERIAL AND METHODS: Fifty patients with AIS, aged 10-18 years, with curves 10-45 °, recruited from a scoliosis clinic were randomized to receive standard of care or supervised Schroth exercises plus standard of care for 6 months. Schroth exercises were taught over five sessions in the first two weeks. A daily home program was adjusted during weekly supervised sessions. The assessor and the statistician were blinded. Outcomes included the Biering-Sorensen (BME) test, Scoliosis Research Society (SRS-22r) and Spinal Appearance Questionnaires (SAQ) scores. Intention-to-treat (ITT) and per protocol (PP) linear mixed effects models were analyzed. Because ITT and PP analyses produced similar results, only ITT is reported. RESULTS: After 3 months, BME in the Schroth group improved by 32.3 s, and in the control by 4.8 s. This 27.5 s difference in change between groups was statically significant (95 % CI 1.1 to 53.8 s, p = 0.04). From 3 to 6 months, the self-image improved in the Schroth group by 0.13 and deteriorated in the control by 0.17 (0.3, 95 % CI 0.01 to 0.59, p = 0.049). A difference between groups for the change in the SRS-22r pain score transformed to its power of four was observed from 3 to 6 months (85.3, 95 % CI 8.1 to 162.5, p = 0.03), where (SRS-22 pain score)(4) increased by 65.3 in the Schroth and decreased by 20.0 in the control group. Covariates: age, self-efficacy, brace-wear, Schroth classification, and height had significant main effects on some outcomes. Baseline ceiling effects were high: SRS-22r (pain = 18.4 %, function = 28.6 %), and SAQ (prominence = 26.5 %, waist = 29.2 %, chest = 46.9 %, trunk shift = 12.2 % and shoulders = 18.4 %). CONCLUSIONS: Supervised Schroth exercises provided added benefit to the standard of care by improving SRS-22r pain, self-image scores and BME. Given the high prevalence of ceiling effects on SRS-22r and SAQ questionnaires' domains, we hypothesize that in the AIS population receiving conservative treatments, different QOL questionnaires with adequate responsiveness are needed. TRIAL REGISTRATION: Schroth Exercise Trial for Scoliosis NCT01610908.